TIDMHCM
RNS Number : 9827J
Hutchmed (China) Limited
03 May 2022
This announcement was first released at 11:00 BST on Monday, 2
May 2022 via Globe Newswire and also submitted to the Hong Kong
stock exchange. It has been uploaded to RNS following the reopening
of the service after the early May Bank Holiday which took place on
Monday, 2 May 2022 in the UK
HUTCHMED Receives Complete Response Letter from the U.S. FDA for
Surufatinib for the Treatment of Advanced Neuroendocrine Tumors
Recording of conference call held on 2 May 2022 available on
HUTCHMED's website
Hong Kong, Shanghai & Florham Park, NJ - Monday, May 2,
2022: HUTCHMED (China) Limited ("HUTCHMED" or the "Company")
(Nasdaq/AIM:HCM; HKEX:13) announced that the U.S. Food and Drug
Administration ("FDA" or the "Agency") has issued a Complete
Response Letter ("CRL") regarding the New Drug Application ("NDA")
for surufatinib for the treatment of pancreatic ("pNETs") and
extra-pancreatic (non-pancreatic, "epNETs") neuroendocrine tumors
("NETs"). FDA determined that the current data package, based on
two positive Phase III trials in China and one bridging study in
the United States (U.S.), does not support an approval in the U.S.
at this time. The CRL indicated that a multi-regional clinical
trial ("MRCT") is required for U.S. approval.
The safety and efficacy of surufatinib, an oral inhibitor of
angiogenesis and immune modulation, was demonstrated in the SANET-p
and SANET-ep studies, two randomized double-blind Phase III trials
in patients with advanced pNETs and epNETs conducted in China.
Results of a HUTCHMED sponsored bridging study conducted in the
U.S. suggest similar safety and efficacy to the SANET study
population in China. Surufatinib was approved in China for the
treatment of pNETs and epNETs in June 2021 and December 2020,
respectively.
Surufatinib received U.S. FDA Fast Track Designations in April
2020 for the treatment of pNETs and epNETs. Orphan Drug Designation
for pNETs was granted in November 2019. In a May 2020 pre-NDA
meeting, HUTCHMED reached an agreement with the FDA that the two
positive Phase III studies of surufatinib in patients with pNETs
and epNETs in China, along with the bridging trial in the U.S.
could form the basis to support a U.S. NDA submission. The FDA
accepted the filing of the NDA on June 30, 2021.
The FDA evaluated the applicability of the SANET studies data
generated in one country to U.S. patients and U.S. medical
practice. The CRL stated that the FDA will require a MRCT that
includes subjects more representative of the US patient population
and aligned to current U.S. medical practice. In addition,
pandemic-related issues concerning inspection scheduling and access
contributed to the FDA action. This action by the FDA is not
related to any safety issues with surufatinib. HUTCHMED is working
with the FDA to evaluate next steps.
Dr Weiguo Su, Chief Executive Officer and Chief Scientific
Officer of HUTCHMED, commented: "Although this decision from the
FDA is disappointing, we remain confident about the clinical value
of surufatinib for NET patients and committed to making surufatinib
available to patients globally. We look forward to working with the
Agency to evaluate its feedback. Throughout the duration of the
U.S. review process, we have been transparent and collaborative
with the FDA. There are very few treatments approved and used in
these rare diseases, and patients and physicians would benefit from
more options to address the unmet medical need. We look forward to
continued engagement with the FDA on developing a plan to bring
surufatinib to patients in the U.S."
HUTCHMED International, headquartered in Florham Park, New
Jersey, drives clinical and regulatory development in the US,
Europe and Japan. Dr Marek Kania, Executive Vice President,
Managing Director and Chief Medical Officer of HUTCHMED
International, commented: "Our global development strategy remains
unchanged. Outside of the U.S. and China, we remain committed to
engaging with regulators in Europe, where our Marketing
Authorization Application ("MAA") submission for surufatinib is
under review, and in Japan where we have an ongoing Japanese
bridging study. Furthermore, our foundational approach is to
conduct multi-regional registration trials, such as our 14-country,
691-patient FRESCO-2 Phase III trial for fruquintinib for patients
with metastatic colorectal cancer which is expected to read-out in
the second half of this year."
Conference call
HUTCHMED hosted a conference call at 8:00 am EDT / 1:00 pm BST /
8:00 pm HKT on Monday, May 2, 2022. A recording of this is
available via HUTCHMED's website at www.hutch-med.com/event/.
About Surufatinib
Surufatinib is a novel, oral angio-immuno kinase inhibitor that
selectively inhibits the tyrosine kinase activity associated with
vascular endothelial growth factor receptors (VEGFR) and fibroblast
growth factor receptor (FGFR), which both inhibit angiogenesis, and
colony stimulating factor-1 receptor (CSF-1R), which regulates
tumor-associated macrophages, promoting the body's immune response
against tumor cells. Its unique dual mechanism of action may be
very suitable for possible combinations with other immunotherapies,
where there may be synergistic anti-tumor effects.
HUTCHMED currently retains all rights to surufatinib
worldwide.
About Surufatinib Development
epNETs in China : On December 29, 2020, surufatinib was granted
drug registration approval in China for the treatment of epNET.
Surufatinib is marketed in China under the brand name SULANDA(R) .
The approval was based on results from the SANET-ep study, a Phase
III trial (clinicaltrials.gov identifier: NCT02588170) in patients
with advanced epNETs conducted in China. The study met the
pre-defined primary endpoint of PFS at a preplanned interim
analysis, and was published in The Lancet Oncology [1] . Median PFS
was significantly longer for patients treated with surufatinib at
9.2 months, compared to 3.8 months for patients in the placebo
group (HR 0.334; 95% CI: 0.223-0.499; p<0.0001). Surufatinib had
an acceptable safety profile, with the most common treatment
related adverse events of grade 3 or worse being hypertension (36%
of surufatinib patients vs. 13% of placebo patients), proteinuria
(19% vs. 0%) and anemia (5% vs. 3%).
pNETs in China : On June 16, 2021, surufatinib was granted drug
registration approval in China for the treatment of pNET. The
approval was based on results from the SANET-p study, a Phase III
trial (clinicaltrials.gov identifier: NCT02589821) in patients with
advanced pNET in China. The pre-defined primary endpoint of PFS was
met at a preplanned interim analysis and was published in The
Lancet Oncology [2] , demonstrating that surufatinib reduces the
risk of disease progression or death by 51% in patients, with a
median PFS of 10.9 months compared to 3.7 months on placebo (HR
0.491; 95% CI: 0.391-0.755; p=0.0011). The safety profile of
surufatinib was manageable and consistent with observations in
prior studies.
Immunotherapy combinations: HUTCHMED entered into collaboration
agreements to evaluate the safety, tolerability and efficacy of
surufatinib in combination with anti-PD-1 monoclonal antibodies,
including with tislelizumab (BGB-A317) and TUOYI(R) (toripalimab),
which are approved as monotherapies in China.
NETs in Europe : An MAA submission to the EMA was validated in
July 2021, which includes data from a U.S. Phase I/II study, as
well as the completed Phase III SANET-ep and SANET-p studies used
to support marketing authorization in China.
NETs in Japan : A Japan registration-enabling bridging study was
initiated in September 2021. Based on dialogue with the Japanese
Pharmaceuticals and Medical Devices Agency (PMDA), it was agreed
that a Japanese NDA include results from a pivotal study to be
conducted in Japan.
The surufatinib Expanded Access Protocol (EAP) in the U.S. will
no longer allow new patients to enroll in the study.
About HUTCHMED
HUTCHMED (Nasdaq/AIM: HCM; HKEX: 13) is an innovative,
commercial-stage, biopharmaceutical company. It is committed to the
discovery and global development and commercialization of targeted
therapies and immunotherapies for the treatment of cancer and
immunological diseases. It has more than 4,600 personnel across all
its companies, at the center of which is a team of over 1,600 in
oncology/immunology. Since inception it has advanced 12 cancer drug
candidates from in-house discovery into clinical studies around the
world, with its first three oncology drugs now approved and
marketed in China. For more information, please visit:
www.hutch--med.com or follow us on LinkedIn.
Forward-Looking Statements
This announcement contains forward-looking statements within the
meaning of the "safe harbor" provisions of the U.S. Private
Securities Litigation Reform Act of 1995. These forward-looking
statements reflect HUTCHMED's current expectations regarding future
events, including its expectations regarding the therapeutic
potential of surufatinib for the treatment of patients with NETs
and the further clinical development of surufatinib in this and
other indications. Forward-looking statements involve risks and
uncertainties. Such risks and uncertainties include, among other
things, assumptions regarding the sufficiency of clinical data to
support NDA approval of surufatinib for the treatment of patients
with NETs in the U.S.,E.U., China, Japan and other jurisdictions ,
its potential to gain approvals from regulatory authorities on an
expediated basis or at all, the safety profile of surufatinib,
HUTCHMED's ability to fund, implement and complete its further
clinical development and commercialization plans for surufatinib,
the timing of these events, and the impact of the COVID-19 pandemic
on regulators' ability to access and inspect clinical sites in
China, and on general economic, regulatory and political
conditions. In addition, as certain studies rely on the use of
tislelizumab, and TUOYI(R) as combination therapeutics with
surufatinib, such risks and uncertainties include assumptions
regarding the safety,
efficacy, supply and continued regulatory approval of these
therapeutics. Existing and prospective investors are cautioned not
to place undue reliance on these forward-looking statements, which
speak only as of the date hereof. For further discussion of these
and other risks, see HUTCHMED's filings with the U.S. Securities
and Exchange Commission, on AIM and on The Stock Exchange of Hong
Kong Limited. HUTCHMED undertakes no obligation to update or revise
the information contained in this announcement, whether as a result
of new information, future events or circumstances or
otherwise.
Inside Information
This announcement contains inside information for the purposes
of Article 7 of Regulation (EU) No 596/2014 (as it forms part of
retained EU law as defined in the European Union (Withdrawal) Act
2018) .
CONTACTS
Investor Enquiries
Mark Lee, Senior Vice President +852 2121 8200
Annie Cheng, Vice President +1 (973) 567 3786
Media Enquiries
Americas - Brad Miles, +1 (917) 570 7340 (Mobile)
Solebury Trout bmiles@troutgroup.com
Europe - Ben Atwell / Alex Shaw, +44 20 3727 1030 / +44 7771 913 902 (Mobile) / +44 7779 545 055 (Mobile)
FTI Consulting HUTCHMED@fticonsulting.com
Asia - Zhou Yi, +852 97 83 6894 (Mobile)
Brunswick HUTCHMED@brunswickgroup.com
Nominated Advisor
Atholl Tweedie / Freddy Crossley,
Panmure Gordon (UK) Limited +44 (20) 7886 2500
[1] Xu J, Shen L, Zhou Z, et al. Surufatinib in advanced
extrapancreatic neuroendocrine tumours (SANET-ep): a randomised,
double-blind, placebo-controlled, phase 3 study. Lancet Oncol.
2020;21(11):1500-1512. doi: 10.1016/S1470-2045(20)30496-4 .
[2] Xu J, Shen L, Bai C, et al. Surufatinib in advanced
pancreatic neuroendocrine tumours (SANET-p): a randomised,
double-blind, placebo-controlled, phase 3 study. Lancet Oncol.
2020; 21(11):1489-1499. doi: 10.1016/S1470-2045(20)30493-9 .
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END
MSCBLLLBLELZBBV
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May 03, 2022 02:01 ET (06:01 GMT)
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